Principal Engineer

PROTEOR; Irvine (CA); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading company in prosthetics is seeking a Principal Engineer to oversee the mechanical design lifecycle of innovative products. The successful candidate will have extensive experience in medical device development, lead engineering projects, and collaborate closely with various teams to ensure successful product commercialization.

Qualifications

• 10+ years of relevant experience required.
• Proven track record in developing mechanical solutions.
• Experience in medical device product development.

Responsibilities

• Lead design and validation of prosthetic components.
• Provide engineering support across teams.
• Manage project budgets and intellectual property submissions.

Skills

Leadership

Problem-solving

Communication

Collaboration

Education

Master’s or Ph.D. in Mechanical Engineering

Tools

SolidWorks

Job description

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This range is provided by PROTEOR. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$150,000.00/yr - $170,000.00/yr

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Reports To: Director of Engineering, Chief Engineer

Location: Irvine, CA (On-Site)

Job Overview

The Principal Engineer is responsible for the full lifecycle of mechanical design development for the company’s prosthetic products, including research, mechanical system design, analysis, requirements, risk analysis, design documentation, development, validation, and verification of all related components.

This will support an expanding operation for commercialization of our next-generation prosthetic feet, ankles, knees, and legs. Working closely with the engineering and operations teams, they will be responsible for the ongoing engineering support of prosthetic limbs.

The ideal candidate will possess strong technical knowledge, experience, and leadership in developing complex mechanical solutions for medical devices. They will have a proven track record as a hands-on engineer and possess the ability to contribute to the development of products from concept to launch.

Key Responsibilities and Duties

• Lead design, development, and release of detailed prosthetic components, subsystems, and complex mechanical systems.
• Plan, design, validate, and implement product changes.
• Lead development and execution of verification and validation plans and protocols, regulatory certifications.
• Provide engineering support to internal and external customers, including manufacturing, sales, clinical services, medical practitioners, and product users.
• Collaborate with Engineering team members to determine feasibility, scope, and feature sets for mechanical-related technologies.
• Responsible for technical leadership and/or mentorship of multiple engineers.
• Develop and manage budgets for projects.
• Serve as subject matter expert for mechanical-related technologies.
• Identify, develop, and prepare submissions for intellectual property.
• Tasks and responsibilities assigned as needed.

Required Skills/Abilities

• Strong ethics, leadership, ambition, drive, and results-oriented.
• Planning, prioritization, organizational, and communication skills
• Knowledge of product development life cycle, including planning, hazard analysis, requirements analysis, detailed design, development, verification, and validation testing in a process-driven environment.
• Working knowledge of design control procedures, design transfer to manufacturing, regulatory requirements, FDA, IEC, CE, ISO, and IEEE.
• Structured problem-solving skills (e.g., Six Sigma, DMIAC) and failure analysis experience desired.
• Expert knowledge of mechanical design, analysis, and FEA.
• High proficiency using computer-aided design (CAD) packages such as SolidWorks.

Education and Experience

• Master’s or Ph.D. degree in Mechanical Engineering or equivalent engineering discipline.
• 10+ years of relevant experience.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at a time.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering, Manufacturing, and Research

• Industries

  Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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